Standards in this guide are end-to-end implementations of CDISC models which are designed to ensure the traceability and transparency of data across activities in the data lifecycle. Implementation of models per this guide with relationships across activities is in relation to activities which support collection, tabulation, analysis, and exchange of data are further described in the table below.
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| Standards for Collection | Standards for Tabulation: The SDTM | Standards for Analysis: The ADaM |
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CDISC CDASH Model - In this guide, the CDASH Model is implemented to support development of CRFs for the Product Impact on Individual Health use case only. The CDASH Model is the earliest model implemented for this use case.
- The CDASH Model defines a basic set of data collection fields that are expected to be present on the majority of CRFs.
- The use of CDASH data collection fields and variables is intended to facilitate facilitates mapping to tabulation datasets implemented implemented from the SDTM structure.
- When submitted data can be collected as it will be represented in an SDTM a tabulation dataset, with no transformations or derivations, the SDTMIG TIG SDTM variable names are presented in the CDASHIG metadata table and should be used TIG CDASH to collect the data.
- In cases where the collected data must be transformed or reformatted prior to inclusion in an SDTM a tabulation dataset, or where a corresponding SDTMIG variable does not exist, CDASH has created standardized data collection variable names.
| CDISC SDTM - The SDTM is implemented for use cases
| CDISC ADaM | | Standards for Data Exchange |
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